Custom API Manufacturing From Early Development To Commercial

As a leading global API CDMO, Siegfried provides integrated process development, analytical development, scale-up, GMP manufacturing, and regulatory support for innovative drug substances – from early phase development to commercial supply.

Your trusted partner for exclusive synthesis

• Expertise: More than 150 years of scientific expertise and advanced process chemistry capabilities enable us to develop efficient, scalable manufacturing processes for even the most demanding APIs
• Reliability: Our global manufacturing network, with integrated dual-supply capabilities and industry-leading operational excellence, ensures a reliable and resilient supply throughout your product lifecycle
• Quality: An impeccable quality track record, built on decades of regulatory and manufacturing excellence, ensures consistently high-quality APIs from development through commercial supply.

Our wide range of services for custom API synthesis

Flexible API contract synthesis from gram to ton scale

Our global manufacturing network scales seamlessly with your program – from gram quantities for early development to commercial-scale production. As your integrated CDMO partner, we manage route design, process development, scale-up, and commercial supply of your drug substance, with seamless transfer into our drug product network to accelerate your path to market

Preclinical and early phase development

At our Siegfried Acceleration Hub in the US we offer comprehensive services for preclinical and early-phase drug development and manufacturing. From phase-appropriate analytical and validation method development to scalable manufacturing processes, we provide the capabilities and support needed to accelerate your path from concept to clinic. Backed with our decades long development and manufacturing experience we ensure a smooth transition into Siegfried’s global manufacturing network from early phase through to commercial production, all from a single partner.

Process development for drug substance manufacturing

Siegfried’s process and chemical development services help establish scalable, cost-effective manufacturing processes tailored to your product’s commercial requirements. Our expert scientists design entirely new synthetic routes or optimize existing ones and work closely with you to set clear development objectives.

Analytical development for API custom synthesis

Our analytical development team works hand in hand with process development to support your product at every phase. Together, we develop robust analytical methods and quality control specifications that support every stage of development.

With more than 500 method validations performed in accordance with ICH guidelines and extensive experience in cGMP compliance, we advise on purity profiles, impurity tracking, limits, structure determination, genotoxic contamination, and heavy metal analysis.

Pilot manufacturing and scale-up in API contract manufacturing

Building on experience from more than 1,600 chemical development projects, we take chemical processes from development and scale them up into robust manufacturing processes. We support your program from early clinical trials through commercial launch and routine manufacturing.

Our versatile cGMP pilot manufacturing and scale-up capabilities at our production sites in Zofingen, Evionnaz, Nantong, and Pennsville accelerate your drug development.

GMP API manufacturing

As your flexible partner, Siegfried provides reliable, consistent commercial supply of high-quality drug substances. Versatile cGMP capabilities and robust, market-tailored processes enable us to manufacture demanding APIs, intermediates, and complex syntheses, including controlled substances and high-potency materials, alongside our API portfolio of generic products.

Regulatory documentation and DMF support

Siegfried prepares, maintains, and submits cGMP-compliant documentation that keeps your filings moving. We author and update Drug Master File (DMF) modules and submission dossiers for global regulatory authorities, including the FDA, EMA, and PMDA, and manage lifecycle updates as your process evolves. Our Siegfried Acceleration Hub supports CMC sections and route scouting from the very first phase.

Analytical methods, validation reports, stability data, and specifications are prepared and provided in a format suitable for submission to international regulatory authorities, offering your regulatory affairs team submission-ready packages from day one.

Technical capabilities for exclusive drug synthesis

Advanced chemistry and process capabilities

Siegfried’s state-of-the-art laboratories and manufacturing facilities support a broad range of chemical and enzyme-catalyzed transformations, enabling efficient development and manufacture of complex drug substances. Our process capabilities cover reaction conditions from –100°C to 300°C and 1 mbar to 40 bar, providing the flexibility required for a wide variety of synthetic routes.

State-of-the-art laboratories

Advanced laboratory automation accelerates process development and deepens process understanding, while dedicated, segregated laboratory facilities enable the safe handling of highly potent compounds with occupational exposure limits (OEL) down to 1 µg/m³.

Particle engineering and solid-state expertise

Our expertise extends beyond synthesis to the critical downstream operations that determine product quality and performance. We optimize crystallization and isolation processes to maximize yield and purity and offer a comprehensive range of particle engineering technologies, including milling, spray drying, micronization, and pre-formulation blending, to achieve the desired physical characteristics.

Scalable manufacturing and technology transfer

Successful commercialization depends on robust and scalable processes. Our process development teams establish safe, sustainable, and economically viable manufacturing routes designed for seamless scale-up. Through our collaboration with the Miniplant 4.0 Association, we leverage advanced digital tools and process insights to accelerate technology transfer and manufacturing readiness.

Comprehensive analytical capabilities

Our chemical and process development capabilities are supported by a comprehensive analytical infrastructure, including HPLC, UPLC, GC, LC-MS, GC-MS, ICP-MS, NMR, IC, DSC/TGA, UV, IR, NIR, Raman spectroscopy, and advanced particle size analysis.

All analytical data, methods, specifications, and reference standards are managed within a validated Laboratory Information Management System (LIMS), ensuring data integrity, regulatory compliance, and submission-ready documentation.